Manager Npi

The Lenti Viral Vector Facility / Pollux project: Janssen Biologics B.V., part of Johnson & Johnson, is setting up a new production facility in Sassenheim. This facility will produce lentiviral vector, which is used at the CAR-T sites for the treatment of several types of blood cancer. The New Product Introduction team (NPI) is an essential support group in the LVV Facility. The team has the following major roles

1. Ensure a smooth tech transfer of new products to the shop floor.

2. Ensures a smooth tech transfer of improvements to existing processes or develops new and improved basic processes

The NPI team is a critical team in the direct support of Operations when it comes to the introduction of new Lenti Viral Vectors. The NPI team is key in clear translation of the developed process to a workable process and environment for the shop floor. The NPI team always works against the high-quality standards and safety and compliance regulations that are applicable for LVV manufacturing. The NPI team is a multifunctional team of around 10 - 15 people consisting of staff and contractor personnel. The NPI team is one of 3 departments within the LVV facility. The other two are: Operations Department (OPS) and CoE.

Essential Job

**Responsibilities**:
The NPI Manager provides leadership and direction for the Process leads, Manufacturing specialist resources and activities. Partners in the LVV facility with Operations and CoE in the introduction of new products and a smooth transition from one product to the other. Encourages and supports the identification and development of innovative solutions to problems and opportunities.
- Acts as project lead of the receiving site
- Support process fit-to-plant methodology
- Facilitates resolution of complex process
- & technical problems.
- Promotes innovation initiatives for new processes, products and ideas.
- Reviews and approves technical documentation to verify compliance to technical specifications and standards.
- Communicates with internal and external departments (R&D, OPS, QA, QC, MAM, MSAT, IT) to coordinate and execute the tech transfer.
- Assigns tasks according to projected scopes including compliance and quality improvement, capacity increase, raw material qualification, and launch preparation.
- Monitors smooth execution of plans and programs at lower levels and cross functionally that impacts the tech transfer
- Supports intime closure of Change Controls
- Allocates proper level of resources to facilitate attainment of goals within established timelines and budgets.
- Ensures departmental and company compliance with all local government and company regulations, policies and procedures for health, safety and environmental compliance.

**Qualifications**:
Minimum Qualification
- or Process engineering

Other Requirements
- 6-8 years relevant work experience as people leader (Supervisor and/or Manager) with leading and directing teams and/or departments.
- 10 years’ experience in Pharmaceutical (GMP) production environment.
- Tangible experience of successful implemented LEAN projects both on content as leadership
- Knowledge of EHSS standards and regulatory requirements in relation to LVV Production
- Knowledge of the production process and GMP requirements.
- Knowledge of Global JJOS methodology and systems.

Key competences:

- Stress resistant: stays calm and emanates peace, also in complex situations. Deals with changing priorities under time pressure.
- Good analytical and problem-solving abilities and abilities to deal with complexity: Interprets facts, makes connections between multiple signals and aims to find root causes. Perceives obstacles, both short
- and mid-term. Shows a high degree of original and independent thinking, often under time pressure, to maintain manufacturing activities.
- Decisive: Supports and takes decisions based on facts, data and the transcending angles (Departmental and business unit transcending). Searches for a balance between the needs of, and the impact on, those involved.
- Quality oriented: checks and coaches the adherence to, and improvement of quality requirements and standards.
- Cooperation and communication: Builds and maintains solid and productive relationships both within and outside of the department. Organizational abilities in a complex environment.
- Leadership: Can lead a team of highly qualified professionals who operate in different fields of expertise while keeping overview, progress, motivation, innovation and delivery on targets on track.

Additional leadership competences:

- Operational leadership: Empowers the NPI team to lead and deliver on the business targets for the next 3-6 months. Demonstrates good people management skills to his/her direct reportees. A high degree of inventiveness and resourcefulness are required to ensure deadlines are achieved, standards maintained, and the individual team member remains motivated and functioning at good efficiency.
- Tactical leadership: Leads the dev